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Manager, Quality Assurance, Polysaccharide
Visp, Valais, Switzerland
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is initiating development of dedicated biologics manufacturing facilities. This position will lead all aspects of manufacturing activities related to Process Validation, commercial Launch, and routine GMP Manufacturing to ensure the efficient and compliant production of Vaxcyte's products.
Working closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development and Regulatory functions as well as with CDMOs; this position will oversee all hands-on operations of Vaxcyte’s GMP manufacturing locations and support the implementation of the global manufacturing network strategy. This role will be responsible for timely, compliant, secure, and uninterrupted supply of Vaxcyte’s innovative therapies. It is necessary to possess solid knowledge of GxP (GMP, GLP, GCP) regulations as well as expertise in running GMP facilities. Cross-functional teamwork and working with CDMOs is paramount in this role. This position will report to the Senior Director QA of Vaxcyte, Visp, Switzerland.
Essential Functions:
- QA Manufacturing representative for Polysaccharide at Vaxcyte.
- Represent QA at internal and external cross functional team meetings.
- Review and approve internal and external documentation for compliance such as, deviations, risk assessments, change controls, and CAPAs.
- Provide thorough QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses.
- Prepare disposition package of Polysaccharides per global applicable regulatory requirements and provide to management for release.
- Review and approve Polysaccharide shipment authorization forms.
- Develop, implement and maintain procedures and policies as they apply to Polysaccharide manufacturing for the Vaxcyte quality organization as needed.
- Drive the establishment of Quality Agreements and other required regulatory documentation according GMP
- Drive resolution of quality performance issues with contract manufacturers and proactively escalate issues to management.
- Provide guidance on supplier manufacturing investigations.
- Support technology transfer activities and review of technology transfer documents.
- Participate in process improvement projects.
- Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.
Requirements:
- BS or BA with at least 5 years Quality Assurance experience.
- In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines.
- Strong attention to detail.
- Knowledge in both clinical and commercial product desired.
- Excellent verbal, written, and interpersonal communication skills.
- Experience leading and contributing through influence and working in cross functional teams.
- Ability to work in a fast-paced team environment, and to consistently meet aggressive timelines while prioritizing tasks for multiple projects.
- Ability to adapt to changing priorities.
- Strong overall knowledge of biologics manufacturing processes and Quality Systems.
- Required experience with good documentation practices, technical writing, and cGMP standards.
Reports to: Senior Director, Quality Assurance
Location: Visp, Switzerland
Compensation:
The compensation package will be competitive and includes an equity component.
#LI-JN1
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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